Vanda Shares Fall Premarket as FDA Again Rejects Hetlioz for Jet Lag

By Colin Kellaher

Shares of Vanda Pharmaceuticals were sharply lower in premarket trading Thursday after the U.S. Food and Drug Administration once again turned away the company's bid for expanded approval of its Hetlioz drug to treat jet-lag disorder.

Vanda said that while the FDA acknowledged positive efficacy from the biopharmaceutical company's controlled clinical trials, the agency concluded that the data don't provide substantial evidence of effectiveness, mainly because controlled phase advance protocols aren't sufficiently analogous to actual jet travel.

Vanda said it respectfully disagrees with the FDA's interpretation, and that it remains committed to working constructively with the agency while pursuing all appropriate avenues to secure a green light for Hetlioz in jet-lag disorder.

Vanda in October said the FDA would once again review Hetlioz for jet lag after it reached a collaborative framework agreement with the agency following a federal appeals court ruling that set aside the FDA's prior rejection of the drug.

The Washington, D.C.-based company on Thursday said it believes the FDA's latest decision doesn't fully reflect the collaborative spirit of its agreement with the agency or address the court's concerns regarding meaningful engagement with the company's study evidence.

Vanda shares, which closed Wednesday at $8.54, were recently down 11% at $7.60 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 08, 2026 07:59 ET (12:59 GMT)